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Guideline Summary
Guideline Title
Vaccine-preventable STDs. In: Sexually transmitted diseases treatment guidelines, 2010.
Bibliographic Source(s)
Centers for Disease Control and Prevention (CDC). Vaccine-preventable STDs. In: Sexually transmitted diseases treatment guidelines, 2010. MMWR Recomm Rep. 2010 Dec 17;59(RR-12):78-85.
Guideline Status

This is the current release of the guideline.

This guideline updates a previous version: Centers for Disease Control and Prevention. Vaccine preventable STDs. Sexually transmitted diseases treatment guidelines. MMWR Recomm Rep 2006 Aug 4;55(RR-11):69-76.

Scope

Disease/Condition(s)
  • Hepatitis A
  • Hepatitis B
Guideline Category
Diagnosis
Management
Prevention
Screening
Treatment
Clinical Specialty
Family Practice
Infectious Diseases
Internal Medicine
Obstetrics and Gynecology
Pediatrics
Preventive Medicine
Intended Users
Advanced Practice Nurses
Health Care Providers
Managed Care Organizations
Nurses
Physician Assistants
Physicians
Public Health Departments
Guideline Objective(s)
  • To update the Sexually Transmitted Diseases Treatment Guidelines 2006
  • To assist physicians and other health-care providers in preventing and treating sexually transmitted diseases (STDs)
Target Population

Persons at risk for infection with hepatitis A virus (HAV) or hepatitis B virus (HBV)

Interventions and Practices Considered

Hepatitis A

Prevention

  1. Hepatitis A vaccine (HAVRIX, VAQTA)
  2. Immune globulin (IG) for intramuscular administration
  3. Combination hepatitis A and B vaccination (Twinrix)

Diagnosis

Serologic testing for presence of immunoglobulin M (IgM) antibody to hepatitis A virus

Treatment/Management

  1. Supportive care
  2. Hospitalization
  3. Postexposure prophylaxis
  4. Special considerations for persons with chronic liver disease (CLD) and advanced human immunodeficiency virus (HIV) infection

Hepatitis B

Prevention

  1. Hepatitis B immunoglobulin (HBIG)
  2. Hepatitis B vaccine (Recombivax HB, Engerix-B)
  3. Combination hepatitis A and B vaccination (Twinrix)

Diagnosis

Serological tests for hepatitis B surface antigen (HBsAg) or presence of IgM antibody to hepatitis B core (anti-HBc) antigen or antibody to hepatitis B surface antigen (anti-HBs)

Treatment/Management

  1. Confirmation of suspected acute or chronic hepatitis B virus infection with laboratory testing
  2. Supportive care for acute infection
  3. Prevaccination antibody screening
  4. Referral for medical follow-up
  5. Referral for treatment of chronic infection
  6. Vaccination and postexposure prophylaxis for contacts
  7. Booster vaccination (not recommended for immunocompetent persons)
  8. Postexposure prophylaxis for persons exposed to blood or body fluids
  9. Screening for hepatocellular carcinoma for patients with chronic hepatitis B
  10. Special considerations for pregnant women and HIV-infected persons
  11. Management of HBsAg-positive persons, including reporting of HBsAg-positive persons to the state or local health department; repeat testing; referral to specialists; and counseling patients and their household, sexual, and needle-sharing contacts about methods to prevent hepatitis B transmission
Major Outcomes Considered
  • Prevalence of hepatitis A and hepatitis B infection
  • Risk for hepatitis A and hepatitis B infection
  • Risk for chronic infection
  • Risk for death from chronic liver disease (e.g., cirrhosis or hepatocellular carcinoma)
  • Development of protective antibody response
  • Rate of transmission

Methodology

Methods Used to Collect/Select the Evidence
Searches of Electronic Databases
Description of Methods Used to Collect/Select the Evidence

Not stated

Number of Source Documents

Not stated

Methods Used to Assess the Quality and Strength of the Evidence
Subjective Review
Rating Scheme for the Strength of the Evidence

Not applicable

Methods Used to Analyze the Evidence
Review of Published Meta-Analyses
Systematic Review with Evidence Tables
Description of the Methods Used to Analyze the Evidence

Beginning in 2008, Centers for Disease Control and Prevention (CDC) staff members and public- and private-sector experts knowledgeable in the field of sexually transmitted diseases (STDs) systematically reviewed literature using an evidence-based approach (e.g., published abstracts and peer-reviewed journal articles), focusing on the common STDs and information that had become available since publication of the 2006 Guidelines for Treatment of Sexually Transmitted Diseases. CDC staff members and STD experts developed background papers and tables of evidence that summarized the type of study (e.g., randomized controlled trial or case series), study population and setting, treatments or other interventions, outcome measures assessed, reported findings, and weaknesses and biases in study design and analysis. CDC staff then developed a draft document on the basis of this evidence-based review.

Methods Used to Formulate the Recommendations
Expert Consensus (Consensus Development Conference)
Description of Methods Used to Formulate the Recommendations

Centers for Disease Control and Prevention (CDC) staff members and invited consultants (including public- and private-sector professionals knowledgeable in the treatment of patients with sexually transmitted diseases [STDs]) assembled in Atlanta, Georgia, in April 2009 for a meeting where all evidence from the literature reviews pertaining to STD management was discussed.

Specifically, participants identified key questions regarding STD treatment that emerged from the literature reviews and discussed the information available to answer those questions. Discussion focused on four principal outcomes of STD therapy for each individual disease: 1) treatment of infection based on microbiologic eradication, 2) alleviation of signs and symptoms 3) prevention of sequelae, and 4) prevention of transmission. Cost-effectiveness and other advantages (e.g., single-dose formulations and directly observed therapy [DOT]) of specific regimens also were discussed. The consultants then assessed whether the questions identified were relevant, ranked them in order of priority, and answered the questions using the available evidence. In addition, the consultants evaluated the quality of evidence supporting the answers on the basis of the number, type, and quality of the studies.

The sections on hepatitis B virus (HBV) and hepatitis A virus (HAV) infections are based on previously published recommendations of the Advisory Committee on Immunization Practices (ACIP).

Rating Scheme for the Strength of the Recommendations

Not applicable

Cost Analysis

Screening for HAV infection might be cost-effective in populations where the prevalence of infection is likely to be high (e.g., persons aged >40 years and persons born in areas of high HAV endemicity). The potential cost-savings of testing should be weighed against the cost and the likelihood that testing will interfere with initiating vaccination.

Method of Guideline Validation
Peer Review
Description of Method of Guideline Validation

Not stated

Recommendations

Major Recommendations

Note from the National Guideline Clearinghouse (NGC) and the Centers for Disease Control and Prevention (CDC): The sections on hepatitis B virus (HBV) and hepatitis A virus (HAV) infections are based on previously published recommendations of the Advisory Committee on Immunization Practices (ACIP).

Several sexually transmitted diseases (STDs) can be effectively prevented through preexposure vaccination with widely available vaccines, including HAV, HBV, and human papillomavirus (HPV). Vaccines for other STDs (e.g., human immunodeficiency virus [HIV] and herpes simplex virus [HSV]) are under development or are undergoing clinical trials. This guidance focuses largely on integrating the use of available vaccines into STD prevention and treatment activities.

Every person being evaluated or treated for an STD should receive hepatitis B vaccination unless already vaccinated. In addition, some persons (e.g., men who have sex with men [MSM] and illegal-drug users [IDUs]) should receive hepatitis A vaccination.

Hepatitis A

Hepatitis A, caused by infection with HAV, has an incubation period of approximately 28 days (range: 15-50 days). HAV replicates in the liver and is shed in high concentrations in feces from 2 weeks before to 1 week after the onset of clinical illness. HAV infection produces a self-limited disease that does not result in chronic infection or chronic liver disease (CLD). However, 10%-15% of patients experience a relapse of symptoms during the 6 months after acute illness. Acute liver failure from hepatitis A is rare (overall case-fatality rate: 0.5%). The risk for symptomatic infection is directly related to age, with >80% of adults having symptoms compatible with acute viral hepatitis and most children having either asymptomatic or unrecognized infection. Antibody produced in response to HAV infection persists for life and confers protection against reinfection.

HAV infection is primarily transmitted by the fecal-oral route, by either person-to-person contact or through consumption of contaminated food or water. Although viremia occurs early in infection and can persist for several weeks after onset of symptoms, bloodborne transmission of HAV is uncommon. HAV occasionally is detected in saliva in experimentally infected animals, but transmission by saliva has not been demonstrated.

In the United States, almost half of all persons with hepatitis A report having no risk factor for the disease. Among adults with identified risk factors, most cases are among international travelers, household or sexual contacts, nonhousehold contacts (e.g., those encountered through play and daycare), and IDUs. Because transmission of HAV during sexual activity probably results from fecal-oral contact, measures typically used to prevent the transmission of other STDs (e.g., use of condoms) do not prevent HAV transmission. In addition, efforts to promote good personal hygiene have not been successful in interrupting outbreaks of hepatitis A. Vaccination is the most effective means of preventing HAV transmission among persons at risk for infection (e.g., MSM, illegal drug users, and persons with CLD), many of whom might seek services in STD clinics.

Diagnosis

The diagnosis of hepatitis A cannot be made on clinical grounds alone; serologic testing also is required. The presence of immunoglobulin M (IgM) antibody to HAV is diagnostic of acute HAV infection. A positive test for total anti-HAV indicates immunity to HAV infection but does not differentiate current from previous HAV infection. Although usually not sensitive enough to detect the low level of protective antibody after vaccination, anti-HAV tests might be positive after hepatitis A vaccination.

Treatment

Patients with acute hepatitis A usually require only supportive care, with no restrictions in diet or activity. Hospitalization might be necessary for patients who become dehydrated because of nausea and vomiting and is critical for patients with signs or symptoms of acute liver failure. Medications that might cause liver damage or are metabolized by the liver should be used with caution among persons with hepatitis A.

Prevention

Two products are available for the prevention of HAV infection: hepatitis A vaccine (see Table 2 in the original guideline document for recommended doses and schedules) and immune globulin (Ig) for intramuscular (IM) administration. Hepatitis A vaccines are prepared from formalin-inactivated, cell-culture—derived HAV and have been available in the United States since 1995, initially for persons aged ≥2 years. In 2005, the vaccines were approved by the U. S. Food and Drug Administration (FDA) for persons aged ≥12 months, and the vaccine is available for eligible children and adolescents aged <19 years through the Vaccines for Children (VFC) program (telephone: 800-232-4636).

Administered IM in a 2-dose series at 0 and 6–12 months, these vaccines induce protective antibody levels in virtually all adults. By 1 month after the first dose, 94%-100% of adults have protective antibody levels; 100% of adults develop protective antibody after a second dose. In randomized controlled trials, the equivalent of 1 dose of hepatitis A vaccine administered before exposure has been 94%-100% effective in preventing clinical hepatitis A. Kinetic models of antibody decline indicate that protective levels of antibody persist for at least 20 years.

IG is a sterile solution of concentrated immunoglobulins prepared from pooled human plasma processed by cold ethanol fractionation. In the United States, IG is produced only from plasma that has tested negative for hepatitis B surface antigen (HBsAg), antibodies to HIV and hepatitis C virus (HCV), and HCV ribonucleic acid (RNA). In addition, the process used to manufacture IG inactivates viruses (e.g., HBV, HCV, and HIV). When administered IM before or within 2 weeks after exposure to HAV, IG is >85% effective in preventing HAV infections.

A combined hepatitis A and hepatitis B vaccine has been developed and licensed for use as a 3-dose series in adults aged ≥18 years (see Table 3 in the original guideline document for recommended doses by age group). When administered IM on a 0-, 1-, and 6-month schedule, the vaccine has equivalent immunogenicity to that of the monovalent vaccines.

Pre-exposure Vaccination

Persons in the following groups who are likely to be treated in STD clinic settings should be offered hepatitis A vaccine: 1) all MSM; 2) illegal drug users (both injection and noninjection drugs); and 3) persons with CLD, including persons with chronic HBV and HCV infection who have evidence of CLD.

Prevaccination Serologic Testing for Susceptibility

Approximately one third of the U.S. population has serologic evidence of previous HAV infection, which increases with age and reaches 75% among persons aged >70 years. Screening for HAV infection might be cost-effective in populations where the prevalence of infection is likely to be high (e.g., persons aged >40 years and persons born in areas of high HAV endemicity). The potential cost-savings of testing should be weighed against the cost and the likelihood that testing will interfere with initiating vaccination. Vaccination of a person who is already immune is not harmful.

Postvaccination Serologic Testing

Postvaccination serologic testing is not indicated because most persons respond to the vaccine. In addition, the commercially available serologic test is not sensitive enough to detect the low, but protective, levels of antibody produced by vaccination.

Postexposure Prophylaxis

Persons who recently have been exposed to HAV and who previously have not received hepatitis A vaccine should be administered a single dose of single-antigen vaccine or IG (0.02 mL/kg) as soon as possible. Information about the relative efficacy of vaccine compared with IG postexposure is limited, and no data are available for persons aged >40 years or those with underlying medical conditions. Therefore, decisions to use vaccine or IG should take into account patient characteristics associated with more severe manifestations of hepatitis A, including older age and CLD.

For healthy persons aged 12 months to 40 years, single-antigen hepatitis A vaccine at the age-appropriate dose is preferred over IG because of vaccine advantages, including long-term protection and ease of administration. For persons aged >40 years, IG is preferred because of the absence of information regarding vaccine performance and the more severe manifestations of hepatitis A in this age group; vaccine can be used if IG cannot be obtained. The magnitude of the risk for HAV transmission from the exposure should be considered in decisions to use IG or vaccine. IG should be used for children aged <12 months, immunocompromised persons, persons who have had diagnosed CLD, and persons for whom vaccine is contraindicated.

If IG is administered to persons for whom hepatitis A vaccine also is recommended, a dose of vaccine should be provided simultaneously with IG. The second vaccine dose should be administered according to the licensed schedule to complete the series. The efficacy of IG or vaccine when administered >2 weeks after exposure has not been established.

Special Considerations

Limited data indicate that vaccination of persons with CLD and of persons with advanced HIV infection results in lower seroprotection rates and antibody concentrations. In HIV-infected persons, antibody response might be directly related to CD4+ levels.

Hepatitis B

Hepatitis B is caused by infection with HBV. The incubation period from the time of exposure to onset of symptoms is 6 weeks to 6 months. The highest concentrations of HBV are found in blood, with lower concentrations in other body fluids including wound exudates, semen, vaginal secretions, and saliva. HBV is more infectious and relatively more stable in the environment than other bloodborne pathogens like HCV and HIV.

HBV infection can be self-limited or chronic. In adults, only approximately half of newly acquired HBV infections are symptomatic, and approximately 1% of reported cases result in acute liver failure and death. Risk for chronic infection is inversely related to age at acquisition; approximately 90% of infected infants and 30% of infected children aged <5 years become chronically infected, compared with 2%-6% of persons who become infected as adults. Among persons with chronic HBV infection, the risk for premature death from cirrhosis or hepatocellular carcinoma (HCC) is 15%-25%.

HBV is efficiently transmitted by percutaneous or mucous membrane exposure to infectious blood or body fluids that contain blood. The primary risk factors associated with infection among adolescents and adults are unprotected sex with an infected partner, unprotected sex with more than one partner, MSM, history of other STDs, and illegal injection-drug use. In addition, several studies have demonstrated the horizontal transmission of HBV, including through premastication, as a less common source of transmission.

The Centers for Disease Control and Prevention's (CDC's) national strategy to eliminate transmission of HBV infection includes 1) prevention of perinatal infection through routine screening of all pregnant women for HBsAg and immunoprophylaxis of infants born to HBsAg-positive mothers or mothers whose HBsAg status is unknown, 2) routine infant vaccination, 3) vaccination of previously unvaccinated children and adolescents through age 18 years, and 4) vaccination of previously unvaccinated adults at increased risk for infection. High vaccination coverage rates, with subsequent declines in acute hepatitis B incidence, have been achieved among infants and adolescents. In contrast, vaccination coverage among most high-risk adult groups (e.g., persons with more than one sex partner in the previous 6 months, MSM, and IDUs) have remained low, and most new infections occur in these high-risk groups. STD clinics and other settings that provide services to high-risk adults are ideal sites in which to provide hepatitis B vaccination to adults at risk for HBV infection. All unvaccinated adults seeking services in these settings should be assumed to be at risk for hepatitis B and should be offered hepatitis B vaccination.

Diagnosis

Diagnosis of acute or chronic HBV infection requires serologic testing (see Table 4 of the original guideline document). Because HBsAg is present in both acute and chronic infection, the presence of IgM antibody to hepatitis B core antigen (IgM anti-HBc) is diagnostic of acute or recently acquired HBV infection. Antibody to HBsAg (anti-HBs) is produced after a resolved infection and is the only HBV antibody marker present after immunization. The presence of HBsAg and total anti-HBc, with a negative test for IgM anti-HBc, indicates chronic HBV infection. The presence of anti-HBc alone might indicate a false-positive result or acute, resolved, or chronic infection.

Treatment

No specific therapy is available for persons with acute hepatitis B; treatment is supportive. Persons with chronic HBV infection should be referred for evaluation to a physician experienced in the management of CLD. Therapeutic agents cleared by FDA for treatment of chronic hepatitis B can achieve sustained suppression of HBV replication and remission of liver disease in some persons. In addition, patients with chronic hepatitis B might benefit from screening to detect HCC at an early stage.

Prevention

Two products have been approved for hepatitis B prevention: hepatitis B immune globulin (HBIG) and hepatitis B vaccine. HBIG provides temporary (i.e., 3-6 months) protection from HBV infection and is typically used as postexposure prophylaxis (PEP) either as an adjunct to hepatitis B vaccination in previously unvaccinated persons or alone in persons who have not responded to vaccination. HBIG is prepared from plasma known to contain high concentrations of anti-HBs. The recommended dose of HBIG is 0.06 mL/kg.

Hepatitis B vaccine contains HBsAg produced in yeast by recombinant DNA technology and provides protection from HBV infection when used for both preexposure immunization and PEP. The two available monovalent hepatitis B vaccines for use in adolescents and adults are Recombivax HB (Merck and Co., Inc., Whitehouse Station, New Jersey) and Engerix-B (GlaxoSmithKline Biologicals, Pittsburgh, Pennsylvania). A combination vaccine (hepatitis A and hepatitis B) for use in adults, Twinrix (GlaxoSmithKline Biologicals, Pittsburgh, Pennsylvania), also is available. The recommended HBV dose varies by product and age of recipient (see Table 3 in the original guideline document for recommended doses by age group).

When selecting a hepatitis B vaccination schedule, the health-care provider should consider the need to achieve completion of the vaccine series. Approved adolescent and adult schedules for both monovalent hepatitis B vaccine (i.e., Engerix-B and Recombivax HB) include the following: 0, 1, and 6 months; 0, 1, and 4 months; and 0, 2, and 4 months. A 4-dose schedule of Engerix-B at 0, 1, 2, and 12 months is licensed for all age groups. A 2-dose schedule of Recombivax HB adult formulation (10 µg) is licensed for adolescents aged 11-15 years. When scheduled to receive the second dose, adolescents aged >15 years should be switched to a 3-dose series, with doses 2 and 3 consisting of the pediatric formulation (5 µg) administered on an appropriate schedule. Twinrix may be administered to persons aged ≥18 years at risk for both HAV and HBV infections at 0, 1, and 6 months.

Hepatitis B vaccine should be administered IM in the deltoid muscle and can be administered simultaneously with other vaccines. For adolescents and adults, the needle length should be 1-2 inches, depending on the recipient's weight (1 inch for females weighing <70 kg, 1.5 inches for males weighing <120 kg; and 2 inches for males and females weighing >120 kg and >100 kg, respectively). A 22- to 25-gauge needle is recommended. If the vaccine series is interrupted after the first or second dose of vaccine, the missed dose should be administered as soon as possible. The series does not need to be restarted after a missed dose.

In adolescents and healthy adults aged <40 years, approximately 30%-55% acquire a protective antibody response (anti-HBs ≥10 milliunits per milliliter [mIU/mL]) after the first vaccine dose, 75% after the second, and >90% after the third. Vaccine-induced immune memory has been demonstrated to persist for at least 15-20 years. Periodic testing to determine antibody levels in immunocompetent persons is not necessary, and booster doses of vaccine are not recommended.

Hepatitis B vaccination is generally well-tolerated by the majority of recipients. Pain at the injection site and low-grade fever are reported by a minority of recipients. For children and adolescents, a causal association exists between receipt of hepatitis B vaccination and anaphylaxis: for each of 1.1 million doses of vaccine administered, approximately one vaccinee will experience this type of reaction. No deaths have been reported in these patients. Vaccine is contraindicated in persons with a history of anaphylaxis after a previous dose of hepatitis B vaccine and in persons with a known anaphylactic reaction to any vaccine component. No evidence for a causal association has been demonstrated for other adverse events after administration of hepatitis B vaccine.

Pre-exposure Vaccination

Hepatitis B vaccination is recommended for all unvaccinated adolescents, all unvaccinated adults at risk for HBV infection, and all adults seeking protection from HBV infection. For adults, acknowledgement of a specific risk factor is not a requirement for vaccination.

Hepatitis B vaccine should be routinely offered to all unvaccinated persons attending STD clinics and to all unvaccinated persons seeking treatment for STDs in other settings. Other settings where all unvaccinated adults should be assumed to be at risk for hepatitis B and should receive hepatitis B vaccination include correctional facilities, facilities providing drug abuse treatment and prevention services, health-care settings serving MSM, and HIV testing and treatment facilities. All persons who receive clinical services in these settings should be offered hepatitis B vaccine, unless they have a reliable vaccination history (i.e., a written, dated record of each dose of a complete series). In all settings, vaccination should be initiated even though completion of the vaccine series cannot be ensured.

Prevaccination Antibody Screening

Prevaccination serologic testing for susceptibility might be considered to reduce the cost of vaccinating adult populations that have an expected high prevalence (20%–30%) of HBV infection (e.g., IDUs and MSM, especially those in older age groups). In addition, prevaccination testing for susceptibility is recommended for unvaccinated household, sexual, and needle-sharing contacts of HBsAg-positive persons.

Anti-HBc is the test of choice for prevaccination testing; persons who are anti-HBc—positive should be tested for HBsAg. If persons are determined to be HBsAg negative, no further action is required. If persons are determined to be HBsAg positive, the person should be referred for medical follow-up to include counseling and evaluation for antiviral treatment (see Management of HBsAg-Positive Persons, below). In addition, all household members, sex partners, and needle-sharing partners of HBsAg-positive persons should be vaccinated.

Serologic testing should not be a barrier to vaccination of susceptible persons, especially in populations that are difficult to access. In most cases, the first vaccine dose should be administered immediately after collection of the blood sample for serologic testing. Vaccination of persons who are immune to HBV infection because of current or previous infection or vaccination does not increase the risk for adverse events.

Postvaccination Testing for Serologic Response

Serologic testing for immunity is not necessary after routine vaccination of adolescents or adults. However, such testing is recommended for persons whose subsequent clinical management depends on knowledge of their immune status (e.g., health-care workers or public safety workers at high risk for continued percutaneous or mucosal exposure to blood or body fluids). In addition, postvaccination testing is recommended for 1) HIV-infected persons and other immunocompromised persons to determine the need for revaccination and the type of follow-up testing; and 2) sex and needle-sharing partners of HBsAg-positive persons to determine the need for revaccination and for other methods to protect themselves from HBV infection.

If indicated, testing should be performed 1-2 months after administration of the last dose of the vaccine series by using a method that allows determination of a protective level of anti-HBs (i.e., ≥10 mIU/mL). Persons determined to have anti-HBs levels of <10 mIU/mL after the primary vaccine series should be revaccinated with a 3-dose series and provided with anti-HBs testing 1-2 months after the third dose. Persons who do not respond to revaccination should be tested for HBsAg. If HBsAg positive, the person should receive appropriate management (see Management of HBsAg-Positive Persons, below); if HBsAg negative, the person should be considered susceptible to HBV infection and counseled concerning precautions to prevent HBV infection and the need for HBIG PEP for any known exposure (see Postexposure Prophylaxis, below).

Postexposure Prophylaxis

Both passive-active PEP (the administration of HBIG and hepatitis B vaccine at separate sites) and active PEP (the administration of hepatitis B vaccination alone) have been demonstrated to be highly effective in preventing transmission after exposure to HBV. HBIG alone also has been demonstrated to be effective in preventing HBV transmission, but with the availability of hepatitis B vaccine, HBIG typically is used as an adjunct to vaccination.

Exposure to HBsAg-Positive Source

Unvaccinated persons or persons known not to have responded to a complete hepatitis B vaccine series should receive both HBIG and hepatitis vaccine as soon as possible (preferably ≤24 hours) after a discrete, identifiable exposure to blood or body fluids that contain blood from an HBsAg-positive source (see the table below). Hepatitis B vaccine should be administered simultaneously with HBIG at a separate injection site, and the vaccine series should be completed by using the age-appropriate vaccine dose and schedule (see Table 3 in the original guideline document). Exposed persons who are in the process of being vaccinated but who have not completed the vaccine series should receive the appropriate dose of HBIG (i.e., 0.06 mL/kg) and should complete the vaccine series. Exposed persons who are known to have responded to vaccination are considered protected; therefore, they need no additional doses of vaccine. Persons who have written documentation of a complete hepatitis B vaccine series and who did not receive postvaccination testing should receive a single vaccine booster dose. Alternatively, these persons can be managed according to guidelines for management of persons with occupational exposure to blood or body fluids that contain blood.

Table: Guidelines for Postexposure Immunoprophylaxis of Unvaccinated Persons Who Have an Identifiable Exposure to Blood or Body Fluids That Contain Blood

Cause Action
Exposure to an HBsAg*-positive source
Percutaneous (e.g., bite or needlestick) or mucosal exposure to HBsAg-positive blood or body fluids that contain blood Administer hepatitis B vaccine and hepatitis B immune globulin (HBIG)†
Sexual or needle-sharing contact of an HBsAg-positive person Administer hepatitis B vaccine and HBIG†
Victim of sexual assault/abuse by a perpetrator who is HBsAg positive Administer hepatitis B vaccine and HBIG†
Exposure to a source with unknown HBsAg status
Victim of sexual assault/abuse by a perpetrator with unknown HBsAg status Administer hepatitis B vaccine†
Percutaneous (e.g., bite or needlestick) or mucosal exposure to blood or body fluids that contain blood from a source with unknown HBsAg status Administer hepatitis B vaccine†

*Hepatitis B surface antigen
†Immunoprophylaxis should be administered as soon as possible, preferably ≤24 hours. Studies are limited on the maximum interval after exposure during which postexposure prophylaxis is effective, but the interval is unlikely to exceed 7 days for percutaneous exposures and 14 days for sexual exposures. The complete, 3-dose hepatitis B vaccine series should be administered.

Exposure to Source with Unknown HBsAg Status

Unvaccinated persons who have a discrete, identifiable exposure to blood or body fluids containing blood from a source with unknown HBsAg status should receive the hepatitis B vaccine series, with the first dose initiated as soon as possible after exposure (preferably within 24 hours) and the series completed by using the age-appropriate dose and schedule. Exposed persons who are not fully vaccinated should complete the vaccine series. Exposed persons with written documentation of a complete hepatitis B vaccine series require no further treatment.

Special Considerations

Pregnancy

All pregnant women receiving STD services should be tested for HBsAg, regardless of whether they have been previously tested or vaccinated. All HBsAg-positive pregnant women should be reported to state and local perinatal hepatitis B prevention programs. HBsAg-negative pregnant women seeking STD treatment who have not been previously vaccinated should receive hepatitis B vaccination. Additional information regarding management of HBsAg-positive pregnant women and their infants is available at http://www.cdc.gov/mmwr/PDF/rr/rr5416.pdf External Web Site Policy.

HIV Infection

HIV infection can impair the response to hepatitis B vaccination. HIV-infected persons should be tested for anti-HBs 1-2 months after the third vaccine dose (see Postvaccination Testing for Serologic Response). Modified dosing regimens, including a doubling of the standard antigen dose and administration of additional doses, might increase the response rate.

Management of HBsAg-Positive Persons

This section provides recommendations for management of all HBsAg-positive persons. Additional recommendations for management of HBsAg-positive persons who are coinfected with HIV are available at http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5315a1.htm External Web Site Policy.

  • All persons with HBsAg-positive laboratory results should be reported to the state or local health department.
  • To verify the presence of chronic HBV infection, HBsAg-positive persons should be retested. The absence of IgM anti-HBc or the persistence of HBsAg for 6 months indicates chronic HBV infection.
  • Persons with chronic HBV infection should be referred for evaluation to a physician experienced in the management of CLD. Some patients with chronic hepatitis B will benefit from early intervention with antiviral treatment or screening to detect HCC at an early stage.
  • Household, sexual, and needle-sharing contacts of chronically infected persons should be identified. Unvaccinated sex partners and household and needle-sharing contacts should be tested for susceptibility to HBV infection (see Prevaccination Antibody Screening, above) and should receive the first dose of hepatitis B vaccine immediately after collection of the blood sample for serologic testing. Susceptible persons should complete the vaccine series by using an age-appropriate vaccine dose and schedule.
  • Sex partners of HBsAg-positive persons should be counseled to use latex condoms to protect themselves from sexual exposure to infectious body fluids (e.g., semen and vaginal secretions), unless they have been demonstrated to be immune after vaccination (anti-HBs ≥10 mIU/mL) or previously infected (anti-HBc positive).
  • To prevent or reduce the risk for transmission to others, HBsAg-positive persons should be advised about the risk for transmission to household, sexual, and needle-sharing contacts and the need for such contacts to receive hepatitis B vaccination. HBsAg-positive persons also should be advised to:
    • Use methods (e.g., condoms) to protect nonimmune sex partners from acquiring HBV infection from sexual activity until the partner can be vaccinated and immunity documented
    • Cover cuts and skin lesions to prevent the spread of infectious secretions or blood
    • Refrain from donating blood, plasma, body organs, other tissue, or semen
    • Refrain from sharing household articles (e.g., toothbrushes, razors, or personal injection equipment) that could become contaminated with blood. In addition, HBsAg-positive persons should refrain from premasticating food provided to susceptible persons.
  • To protect the liver from further harm, HBsAg-positive persons should be advised to:
    • Avoid or limit alcohol consumption because of the effects of alcohol on the liver
    • Refrain from starting any new medicines, including over-the-counter (OTC) and herbal medicines, without checking with their health-care provider
    • Obtain vaccination against hepatitis A if liver disease is determined to be present

When seeking medical or dental care, HBsAg-positive persons should be advised to inform their healthcare providers of their HBsAg status so that they can be appropriately evaluated and managed. The following counseling messages should be considered for HBsAg-positive persons:

  • HBV is not spread by hugging, coughing, food or water, sharing eating utensils or drinking glasses, or casual contact.
  • Persons should not be excluded from work, school, play, child care, or other settings because they are infected with HBV.
  • Involvement with a support group might help patients cope with chronic HBV infection.
Clinical Algorithm(s)

None provided

Evidence Supporting the Recommendations

Type of Evidence Supporting the Recommendations

The type of supporting evidence is not specifically stated for each recommendation.

Throughout this guideline document, the evidence used as the basis for specific recommendations is discussed briefly. More comprehensive, annotated discussions of such evidence will appear in background papers that will be published in a supplement issue of the journal Clinical Infectious Diseases.

Benefits/Harms of Implementing the Guideline Recommendations

Potential Benefits
  • Appropriate diagnosis, management and treatment of patients who have viral hepatitis A or B
  • Reduction in the risk of contacts acquiring hepatitis A or B from infected persons
  • Reduction in the risk of acquiring hepatitis A or B after inadvertent exposure by means of postexposure prophylaxis
  • Decreased rates of infection of viral hepatitis A or B
Potential Harms

Hepatitis B Vaccine

Pain at the injection site and low-grade fever are reported by a minority of recipients. For children and adolescents, a causal association exists between receipt of hepatitis B vaccination and anaphylaxis: for each of 1.1 million doses of vaccine administered, approximately one vaccinee will experience this type of reaction.

Contraindications

Contraindications

Hepatitis B vaccine is contraindicated in persons with a history of anaphylaxis after a previous dose of hepatitis B vaccine and in persons with a known anaphylactic reaction to any vaccine component.

Qualifying Statements

Qualifying Statements

These recommendations should be regarded as a source of clinical guidance and not prescriptive standards; health-care providers should always consider the clinical circumstances of each person in the context of local disease prevalence. The recommendations are applicable to various patient-care settings, including family planning clinics, private physicians' offices, managed care organizations, and other primary-care facilities. These guidelines focus on the treatment and counseling of individual patients and do not address other community services and interventions that are essential in sexually transmitted disease (STD)/human immunodeficiency virus (HIV) prevention efforts.

Implementation of the Guideline

Description of Implementation Strategy

An implementation strategy was not provided.

Implementation Tools
Mobile Device Resources
Resources
Slide Presentation
Staff Training/Competency Material
For information about availability, see the Availability of Companion Documents and Patient Resources fields below.

Institute of Medicine (IOM) National Healthcare Quality Report Categories

IOM Care Need
Getting Better
Staying Healthy
IOM Domain
Effectiveness
Patient-centeredness
Timeliness

Identifying Information and Availability

Bibliographic Source(s)
Centers for Disease Control and Prevention (CDC). Vaccine-preventable STDs. In: Sexually transmitted diseases treatment guidelines, 2010. MMWR Recomm Rep. 2010 Dec 17;59(RR-12):78-85.
Adaptation

Not applicable: The guideline was not adapted from another source.

Date Released
1993 (revised 2010 Dec 17)
Guideline Developer(s)
Centers for Disease Control and Prevention - Federal Government Agency [U.S.]
Source(s) of Funding

United States Government

Guideline Committee

Not stated

Composition of Group That Authored the Guideline

Chairperson: Kimberly A. Workowski, MD, National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention (NCHHSTP), CDC and Emory University, Atlanta, Georgia

Presenters: Heidi Bauer, MD, California Sexually Transmitted Disease Control Branch, Oakland, California; Laura Bachman, MD, Wake Forest University; Gale Burstein, MD, MPH, Erie County Department of Health; Linda Eckert, MD, University of Washington; William M. Geisler, MD, University of Alabama, Birmingham, Alabama; Khalil Ghanem, MD, Johns Hopkins University; Matt Golden, MD, MPH, University of Washington; Linda Gorgos, MD, New Mexico Department of Health; Margaret Hammerschlag, MD, State University of New York, Downstate Medical Center, Brooklyn, New York; Lisa Hollier, MD, University of Texas at Houston; Peter Leone, MD, University of North Carolina School of Medicine, Chapel Hill, North Carolina; Jeanne Marrazzo, MD, University of Washington, Seattle, Washington; Kenneth Hugh Mayer, MD, Brown University Medical School, Providence, Rhode Island; Paul Nyirjesy, MD, Drexel University College of Medicine, Philadelphia, Pennsylvania; Anne Rompalo, MD, Johns Hopkins School of Medicine, Baltimore, Maryland; Pablo Sanchez, MD, University of Texas Southwestern Medical Center, Dallas, Texas; Bradley Stoner, MD, PhD, Washington University, St. Louis, Missouri; Anna Wald, MD, University of Washington, Seattle, Washington; George Wendel, MD, University of Texas Southwestern Medical School, Dallas, Texas; Harold C. Wiesenfeld, MD, University of Pittsburgh, Pittsburgh, Pennsylvania

Moderators: Willard Cates, Jr., MD, MPH, Family Health International, Durham, North Carolina; King K. Holmes, MD, PhD, University of Washington, Seattle, Washington; David Martin, MD, Louisiana State University Medical Center, New Orleans, Louisiana

Rapporteurs: Hunter Handsfield, MD, University of Washington, Seattle, Washington; William McCormack, MD, State University of New York Health Science Center, Brooklyn, New York; William M. Geisler, MD, University of Alabama, Birmingham, Alabama

Consultants: N. Franklin Adkinson, MD, Johns Hopkins University; William Andrews, MD, PhD, University of Alabama, Birmingham; Michael Augenbraun, MD, State University of New York Health Science Center, Brooklyn, New York; Bryon Batteiger, MD, University of Indiana; Gail Bolan, MD, California Department of Health, Oakland, California; Bruce Coles, DO, New York Department of Health; Carolyn Deal, PhD, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland; J. Dennis Fortenberry, MD, Indiana University School of Medicine, Indianapolis, Indiana; Edward Hook, III, MD, University of Alabama, Birmingham, Alabama; Jane R. Schwebke, MD, University of Alabama, Birmingham, Alabama; Joann Schulte, DO, National Institutes of Health, Bethesda, Maryland; David Soper, MD, Medical University of South Carolina, Charleston, South Carolina; Lawrence Stanberry, MD, PhD, University of Texas Medical Branch, Galveston, Texas; Bruce Trigg, MD, New Mexico Department of Health; Yolanda Wimberly, MD, Morehouse School of Medicine; Jonathan M. Zenilman, MD, Johns Hopkins Bayview Medical Center, Baltimore, Maryland

Liaison Participants: Kaytura Aaron, MD, HRSA; Laura Bachman, MD, HIV Association of America; Lynn Barclay, MD, American Social Health Association; Margaret J. Blythe, MD, American Academy of Pediatrics; Carolyn D. Deal, PhD, National Institutes of Health; Jordon Dimitrakov, MD, PhD, American Urological Association; Mark FitzGerald, MD, British Association for Sexual Health and HIV, Southampton, United Kingdom; Dennis Fortenberry, MD, Society of Adolescent Medicine; Edward W. Hook, III, MD, Infectious Disease Society of America; Noreen Jack, MD, Pan American Health Association; Peter Kerndt, MD, National Coalition of STD Directors; Jeanne Marrazzo, MD, American Sexually Transmitted Diseases Association; Francis J. Ndowa, MD, World Health Organization, Geneva, Switzerland; Michael Parkinson, MD, American College of Preventative Medicine; Jeffrey Piepert, MD, American College of Obstetrics and Gynecology; Patricia Reams, MD, National Commission on Correctional Health Care; Bisan Salhi, MD, American College of Emergency Physicians; Karen Shea, MSN, Planned Parenthood Federation of America; David Soper, MD, Infectious Diseases Society for Obstetrics and Gynecology; Bradley Stoner, MD, PhD, CDC STD Prevention Training Centers; Amy Swann, Association of Reproductive Health Professionals; Litjen Tan, PhD, American Medical Association; Tom Wong, MD, Public Health Agency of Canada, Ottawa, Ontario, Canada

CDC, Division of Sexually Transmitted Disease Prevention Treatment Guidelines 2010 Project Coordinator: Kimberly A. Workowski, MD, NCHHSTP, CDC and Emory University, Atlanta, GA

Project Manager: Richard Voigt, NCHHSTP, CDC, Atlanta, Georgia

NCHHSTP/CDC Presenters: Deblina Datta, MD; Eileen Dunne, MD; Matthew Hogben, PhD; Scott Holmberg, MD; Emily Koumans, MD; Lori Newman, MD

CDC Consultants: Sevgi O. Aral, PhD; Ronald Ballard, PhD; Bernard Branson, MD; John Brooks, MD, MPH; John Douglas, MD; Alison Friedman; Dale Hu, MD; Peter Kilmarx, MD; John Papp, PhD; Phil Spradling, MD

Support Staff: Brenda Kelley, Valerie Barner, and Deborah McElroy, NCHHSTP, CDC, Atlanta, Georgia

Financial Disclosures/Conflicts of Interest

Not stated

Guideline Status

This is the current release of the guideline.

This guideline updates a previous version: Centers for Disease Control and Prevention. Vaccine preventable STDs. Sexually transmitted diseases treatment guidelines. MMWR Recomm Rep 2006 Aug 4;55(RR-11):69-76.

Guideline Availability

Electronic copies: Available from the Centers for Disease Control and Prevention (CDC) Web site External Web Site Policy.

Print copies: Available from the Centers for Disease Control and Prevention, MMWR, Atlanta, GA 30333. Additional copies can be purchased from the Superintendent of Documents, U.S. Government Printing Office, Washington, DC 20402-9325; (202) 783-3238.

Availability of Companion Documents

The following are available:

  • The Centers for Disease Control and Prevention (CDC) sexually transmitted diseases (STD) treatment guidelines, 2010. eBook for iPad, iPhone, and iPod Touch. Available from the CDC Web site External Web Site Policy.
  • 2010 STD treatment guidelines webinar: an overview by CDC and the National Network of STD/HIV Prevention Training Centers (NNPTC), including continuing medical education (CME) activity. Available from the CDC Web site External Web Site Policy. Slides from the webinar are also available from the CDC Web site External Web Site Policy.
  • Sexually transmitted diseases treatment guidelines, 2010. Pod cast. Available from the CDC Web site External Web Site Policy.
Patient Resources

None available

NGC Status

This summary was completed by ECRI on September 5, 2002. This summary was updated by ECRI on October 13, 2006 and September 13, 2011.

Copyright Statement

No copyright restrictions apply.

Disclaimer

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